News

City Council meeting discusses proposed level 4 research moratorium

by Michele D.  Maniscalco
Thursday Aug 25, 2016

With about 25 spectators in the gallery, City Council president Ayanna Pressley, District 7 city councilor Tito Jackson and councilor at large Annissa Essaibi-George held a meeting on August 11 to hear panels from Roxbury Safety Net and its allies, Boston University's (BU) research and NEIDL (National Emerging Infectious Diseases Laboratory) leadership and the Boston Public Health Commission (BPHC) as well as members of the public on the proposed moratorium on all level 4 potential pandemic research, pending a national review.

While Councilor Essaibi-George had to leave early due to schedule conflicts, she pledged to listen to the proceedings in their entirety via the City Council's on-line video library, with special attention to testimony from the public. Pressley and Jackson had pointed questions for proponents of approving level 4 research at the NEIDL, or Biolab as it is also known, about the economic impact of level 4 research for BU and for the city; on community engagement in the Institutional Biosafety Committee, the Community Liaison Committee and the Boston Biosafety Committee and on BU's self-oversight of labs handling dangerous pathogens.

In his opening remarks, Jackson said, "I come to you this evening heavy hearted because we should not be here in the City of Boston to have a biosafety level 4 lab that is placed in one of the most densely populated neighborhoods and across the street from some of our most vulnerable people; in an area where we have a disproportionate number of individuals suffering from issues like addiction. I really wish that Boston University would help the people dealing with addiction and lowering the mortality rates instead of studying biosafety level 4 agents.The risk of a biosafety level 4 lab in such a densely populated area is not worth it."

Jackson noted that there is a highway, several transfer stations and three methadone clinics I find it objectionable that with the objection of so many people in the community that we would move forward with this lab."

Citing his experience in the pharmaceutical industry, Jackson refuted the argument prohibiting level 4 research would limit Boston's chances to attract biotech businesses and research, noting that Cambridge passed a level 4 research ban years ago but continues to attract biomedical and biotech companies.

Testifying for the Roxbury Safety Net panel, Laura Maslow-Armand, staff attorney at Lawyers Committee for Equal Rights and Economic Justice, called BU's decision to locate the NEIDL, with its intended mission of researching deadly pathogens for which there is no cure in a densely populated area, "unilateral and unfortunate."

Citing some of the level 4 pathogens targeted for study such as Ebola, dengue, monkey fever and lassa fever, Maslow-Armand said they do not pose a current risk to Boston and argued that public health dollars should go instead toward research on HIV-AIDS, bug-resistant tuberculosis, hypertension and other common health threats. She added that NEIDL's location violates President Clinton's 1994 executive order 12898, later reaffirmed by President Obama, requiring that any facility posing a health or pollution risk should first be discussed with the community. The NEIDL was built in 2002 with no prior community engagement or approval process. "There has never been an invitation to the community to mitigate the risk," she said.

Maslow-Armand also claimed that BPHC does not have sufficient inspection resources for already-existing labs in Boston let alone the proposed level 4 lab. Maslow-Armand also cited the Centers for Disease Control's (CDC) lapses in inspector training, security, inventory control and facility maintenance as concerns with respect to level 4 research.

Biomedical research scientist Marc Pelletier said that while he fully supports research on infectious diseases and cancer, he does not support research that poses more risk than benefit to the community. Pelletier called BPHC officials' testimony at a 2014 City Council hearing on the Biolab "grossly misleading." He refuted BPHC's 2014 testimony on whether there would be aerosolized pathogens in the NEIDL's level 4 lab and other issues, playing a recording of former BPHC chief Barbara Ferrer's and BPHC Infectious Disease Bureau director Anita Barry's testimony and offering citations refuting their claims.

To refute earlier testimony regarding the safety of storage of the pathogens, Pelletier produced lab containers to demonstrate how easily the containers could overturned in the event of an attack or accident. Pelletier also recalled BU's failure to report in a timely manner a 2005 incident that resulted in exposure of several researchers to tularemia. The incident was reported to public health authorities 9 days later rather than within 48 hours as required by state law. Overall, Pelletier alleged "collusion" between BPHC and BU to bolster BU's access to research funding by attempting to fast-track NEIDL approval. Dr. Lynn Klotz of the Center for Arms Control and Non-Proliferation testified that many scientists, including Nobel laureates, consider the proposed level 4 research highly dangerous and said there are safer, better ways to conduct such research without live specimens of pandemic viruses.

Mary Crotty, a nurse-attorney with the 23,000 member Massachusetts Nurses Association (MNA), said that MNA claimed many documented cases in which the CDC and the National Institutes of Health (NIH) mishandled dangerous pathogens in labs and in shipping. Crotty also mentioned the recent emergence of exotic infectious diseases such as Zika, Ebola and West Nile virus for which most hospitals are not prepared in the event of an outbreak. Crotty called the siting of a level 4 lab in a largely minority and low income area "environmental racism".

BPHC executive director Monica Valdes Lupi's testimony was largely procedural, outlining the permitting process for approval of biosafety level 3 labs, inspection protocols and the emergency management plan for first responders and publich health personnel in the event of a disaster or release at the NEIDL. Valdes Lupi explained that BPHC must be notified if anyone with access to a lab is exposed to high risk agents, has symptoms of infection or is diagnosed with infection or if security equipment malfunctions or is altered in labs handling high-risk agents. Valdes Lupi called the regulations among the most robust in the country for this type of research.

Councilor Jackson asked whether BPHC will notify the public of any incident that could cause risk to the public or whether it will use its own discretion on notifying neighbors of such incidents. Dr. Anita Barry of BPHC's Infectious Disease Bureau said that BPHC would perform "risk assessment" to determine whether to notify neighbors and the public.

Valdes Lupi also stated that research to make a high-risk agent suitable for use in a biological weapon is prohibited in Boston and there is also also a ban in Boston on high-risk agents designated by presidential order. Laboratories in Boston are prohibited from withholding information on their research from the BPHC on the grounds that it is "classified".

The Biosafety working group has no residents and the Boston Biosafety Committee (BBC) does have two residents among its 12 members, although none are dissenters on level 4 research. Jackson offered help in finding qualified residents to join the BBC and said there should not be a "threshold" of support for level 4 research.

BU vice president and associate provost for research Gloria Waters, who oversees all of BU's research endeavors at both of its campuses, said, "The sole purpose of the NEIDL's research is to improve human health," and added, "Boston University does not carry out classified research." Waters said that all NEIDL research is scrutinized at federal state and local levels by NIH, CDC, the Department of Justice, the Department of Homeland Security, the Massachusetts Water Resources Authority (MWRA), the Massachusetts Emergency Management Agency (MEMA) and the Department of Environmental Protection (DEP).

Corley said he was "concerned about the unintended consequence of proposed research moratorium", adding that emerging and re-emerging infectious diseases can be a threat to the local community even if they are present in Boston through worldwide travel.

Jackson listed the 15 most common causes of death in greater Boston including heart disease, stroke, diabetes, Alzheimer's disease, colorectal cancer, pancreatic cancer and poisoning, questioning the relevancy of the NEIDL's research to the city of Boston. Waters responded that BU researchers are working on all of the illnesses on Jackson's list and is leading the state in developing treatments for opioid addiction at BU's medical center.

To Jackson's inquiry about the funding and financial structure of BU's research programs, Waters replied that NIH funding has declined since construction of the NEIDL and BU now has a net cost of 25 cents on every dollar's worth of research.

Pressley questioned BU's assertion of level 4 research bringing jobs to the community as the jobs in the facility are specialized and not accessible to many local residents and wanted to know what BU is doing to provide "pipelines to employment" in STEM (Science, Technology, Engineering and Math) occupations residents, especially women and people of color.

There were six members of the public who testified, four opposed to level 4 research in Boston including a member of the state committee of the Massachusetts Green/Rainbow Party and a former spokesperson for the president of U. Mass. Boston who was skeptical of BU's claim that it loses money on research, considered a vital source of funds at U. Mass. Boston and other colleges. The presidents of the Boston Municipal Research Bureau and the Association of Independent Colleges and Universities in Massachusetts (AICUM) testified against the moratorium on level 4 research.

Klare X. Allen, founder of Roxbury Safety Net, volunteered to save her remarks for the end to avoid decreasing others' speaking time. Allen recalled that Pelletier and others in the Safety Net coalition applied repeatedly for spots on the CLC, the IBC and the BBC but were ignored. Allen said that several years ago when the CLC held meetings at the Cathedral High School gym, as many as 150 people would attend and many would ask pointed questions, at which point BU stopped holding the meetings.

Allen also noted recent problems in the CDC's safety protocols and inspections at level 4 labs around the country and wondered why BU considers itself capable of infallible safety and compliance with a level 4 facility. Allen voiced concerns about the NEIDL's aerosol lab and the insectarium, which has not been discussed. "We are not against science, but we have to think about the 'what ifs'."

Addressing the absent councilors, Allen said they need to become knowledgeable on the issue and think about what must be done in the event of a disaster at the NEIDL. For example, Allen said that the Boston Fire Department has said it will go to the NEIDL but will not go in to put out a fire. "Who puts out the fires there? Who are these people?" Allen wondered. "We can't say that won't happen and if it does, after 14 years we are not prepared."